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Platelet Lysate and Bioadhesive Compositions Thereof for the Treatment of Mucositis

a technology of platelet lysate and composition, applied in the field of medicine, can solve the problems of no entirely satisfactory therapeutic agent, no therapeutic agent at all, and difficult to reach or subject to removal mechanisms of therapeutic agents,

Inactive Publication Date: 2011-11-17
BIOMED DEVICE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention is about using platelet lysate as a medicament to treat and prevent mucositis and corneal lesions. The lysate has specific characteristics that make it effective in treating these conditions. The invention also includes a pharmaceutical preparation containing the platelet lysate and a mucoadhesive composition that can be applied to the affected areas. The composition contains a carrier and the platelet lysate and can be used as a medicament for treating mucositis and corneal lesions. The invention also includes a process for preparing the composition and a method for using it for therapy and prophylaxis of mucositis and corneal lesions."

Problems solved by technology

Often, the success of the therapy greatly depends upon the location and the anatomical-physiological characteristics of the site covered by the lesion, which, for example, can be difficult to reach or subject to removal mechanisms of the therapeutic agent.
This problem occurs, for example, in the case of mucositis, for which no entirely satisfactory therapeutic agent has yet been described.
The compounds for therapy used up to now have proven to have little activity, are difficult to apply or else, once applied, easily move away or are removed from the site, for example, by physiological secretions or by swallowing movements in the case of buccal mucositis.
Consequently, the active ingredients stay in contact with the mucosa to be treated for an insufficient time, thus slowing down the healing process.
Indeed, the therapeutic effect is not carried out apart from to a minimal extent and, because the first symptoms of healing can occur, it is necessary to perform a continuous and repeated application of the therapeutic agent, which is not always possible, is inconvenient and often unacceptable to the patient.
Similar problems are also encountered in the case of corneal lesions; indeed, the site involved is difficult to reach and the residency time of the active ingredient, often cannot be ensured for a long time period due to lachrymal secretions.

Method used

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  • Platelet Lysate and Bioadhesive Compositions Thereof for the Treatment of Mucositis
  • Platelet Lysate and Bioadhesive Compositions Thereof for the Treatment of Mucositis
  • Platelet Lysate and Bioadhesive Compositions Thereof for the Treatment of Mucositis

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of composition 1

[0084]a) Preparation of the Carrier

[0085]A gel based upon polyacrylic acid (carbopol 974-P NF) is prepared having the following composition:[0086]carbopol 5% (p / p)[0087]saccharin 0.2% (p / p)[0088]flavourings 0.2% (p / p)[0089]NaOH4N up to pH 7.

[0090]In particular, the saccharin is dissolved in a physiological solution (0.9% weight / volume of NaCl) through magnetic agitation. Carbopol is added and the mixture is kept under agitation until complete hydration (about 12 hours). When hydration is complete, a flavouring is added, for example mint, liquorice or strawberry. The formulation is then buffered to pH 7 through the use of a solution of NaOH4N in order to obtain the gelification of the carbopol and thus a formulation having a pH compatible with the mucosa of the oral cavity.

[0091]The carrier thus prepared is then poured into a heat-resistant glass bottle, the empty space at the top is filled with nitrogen and it is subjected to sterilisation with damp heat ...

example 2

Preparation of Composition 2

[0094]a) Preparation of the Carrier for Composition 2

[0095]A gel based upon chitosan and hydroxypropylmethylcellulose (HPMC) was prepared with the following composition:[0096]chitosan glutamate 6% (p / p)[0097]HPMC 2% (p / p)

[0098]The hydroxypropylmethylcellulose is hydrated with a minimum amount of distilled water.

[0099]Chitosan glutamate is added until a concentration of 6% p / p is obtained and the whole thing is brought up to volume with water and kept under mild agitation until the complete hydration of the polymers.

[0100]The pH of the carrier thus prepared is equal to 5.5.

[0101]The gel is then poured into a heat-resistant glass bottle, the empty space at the top is filled with nitrogen and it is subjected to sterilisation with damp heat in an autoclave for 15 minutes at 121° C.

[0102]b) Preparation of Composition 2

[0103]The carrier obtained in step a) is then mixed with platelet lysate in a 1:1 weight ratio up to a final concentration of chitosan glutamate...

example 3

Characteristics of Composition 1

[0104]The composition 1 has a pH value equal to about 7 and rheological properties suitable for application in the oral cavity: apparent viscosity at 50 s−1 equal to about 4.5 Pa·s.

[0105]The composition has properties of mucoadhesion as illustrated in FIG. 2.

[0106]The composition maintains the ability to promote cellular proliferation even after conservation at a temperature of 4-8° C. for 10-15 days as represented in FIG. 4.

[0107]The composition 1 in a preliminary in vivo study proved effective in the treatment of mucositis in five patients suffering from mucositis of the oral cavity of grade III-IV.

[0108]In particular, in 4 such patients the response involved a recovery of the integrity of the damaged of between 50% and 100% and only in one case was it less than 50%. In just one patient with grade I mucositis was there no response.

[0109]No patients suffered local infections as a result of application of the lysate in mucoadhesive carrier.

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Abstract

The present invention concerns the use of platelet lysate for treating and / or preventing mucositis. Moreover, a mucoadhesive composition comprising such a platelet lysate for the therapy and / or prevention of mucositis and of corneal lesions is described.

Description

[0001]This application is a continuation of international application PCT / IT2008 / 000744 filed Dec. 5, 2008.BACKGROUND OF THE INVENTION[0002]The present invention finds application in the field of medicine; more specifically, it concerns compositions for the prevention and treatment of mucositis and of corneal lesions.[0003]In many studies, both in vitro and in vivo, it has been demonstrated how effective growth factors are in promoting cellular proliferation and differentiation, chemiotaxis and synthesis of the extracellular matrix involved in the tissue healing process. Such factors have also been delivered in different release systems. For example, porous three-dimensional polymeric matrices based upon copolymers of lactide and glycolide (PLG) have been proposed to deliver angiogenic factors like the endothelial vascular growth factor (M. H. Sheridan et al., Bioabsorbable polymer scaffolds for tissue engineering capable of sustained growth factor delivery, J. Controlled Release 64...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K35/14A61P29/00A61P27/02A61K35/16A61K35/19
CPCA61K9/006A61K35/16A61K35/19A61K2300/00A61P17/00A61P27/02A61P29/00
Inventor CARAMELLA, CARLA MARCELLABONFERONI, MARIA CRISTINAROSSI, SILVIA STEFANIASANDRI, GIUSEPPINAFERRARI, FRANCAPEROTTI, CESARE GIUSEPPEDEL FANTE, CLAUDIA
Owner BIOMED DEVICE
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